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June 28, 2022
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Acutus announces FDA clearance, launch of access system for LAA closure

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Acutus Medical announced the FDA clearance and commercial launch of its new left-heart access system for use with the Boston Scientific’s left atrial appendage closure device.

According to a company press release, the system (AcQCross Qx) is the first transseptal system with an integrated needle and dilator to reduce the number of cross-septum needle and wire exchanges during left atrial appendage (LAA) closure.

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The product is designed for use with Boston Scientific’s LAA closure system (Watchman; Watchman TruSeal; Watchman FXD Curve).

The transseptal system catheters are length-, diameter- and tip-matched and designed to lock into the hub of most widely available sheaths for left-heart access, according to the release.

“Crossing the septum at the proper location is important when doing any left-sided heart procedure, but it can be especially critical to the success of delivering Watchman to the left atrial appendage,” Thomas Waggoner, DO, FACC, FSCAI, FSVM, RPVI, director of the structural heart program and cardiovascular research at Tucson Medical Center in Tucson, Arizona, said in the release. “With AcQCross, I can easily reposition without withdrawing or exchanging needles or wires, so its new compatibility with Watchman has made my procedures much safer for my patients and far more efficient for me and my team.”